A multicenter, randomized controlled trial of single and multiple dose regimes of oxfendazole for mild (one or two lesions) parenchymal brain cysticercosis

奥芬达唑单剂量和多剂量方案治疗轻度（一处或两处病变）脑实质囊尾蚴病的多中心、随机对照试验

• 批准号: 10704359
• 负责人: Hector Hugo Garcia
• 金额: $ 51.47万
• 依托单位: UNIVERSIDAD PERUANA CAYETANO HEREDIA
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-01 至 2028-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10704359
• 关键词: Aftercare; Albendazole; Antiparasitic Agents; Brain; Central Nervous System; Childhood; Cicatrix; Clinical; Clinical effectiveness; Cognitive deficits; Cohort Studies; Combined Modality Therapy; Cyst; DNA; Data; Developed Countries; Development; Diagnosis; Disease; Dose; Double-Blind Method; Early identification; Epilepsy; Evaluation; Future; Geographic Locations; Gliosis; Goals; Human; Image; Immigrant; India; Individual; Infection; Larva; Lesion; Leukocytes; Magnetic Resonance Imaging; Morbidity - disease rate; Names; Neurocysticercosis; Neurologic; Oral; Parasites; Peru; Population; Praziquantel; Principal Investigator; Prognosis; Publications; Quality of life; Radiology Specialty; Randomized, Controlled Trials; Regimen; Residual state; Resolution; Safety; Sampling; Seizures; Serum; Taenia solium; Testing; Urine; Ventricular; arm; calcification; cohort; comparative efficacy; diagnostic assay; efficacy evaluation; hippocampal atrophy; imaging biomarker; improved; long-term sequelae; magnetic resonance imaging biomarker; programs; response; safety assessment; tool; treatment choice

Oxfendazole in Neurocysticercosis Principal Investigator/Program Director: GARCIA, Hector H. A multicenter, randomized controlled trial of single and three-dose regimens of oxfendazole for mild (one or two lesions) parenchymal brain cysticercosis SUMMARY Taenia solium neurocysticercosis (NCC), the infection of the human central nervous system by the cystic larvae of Taenia solium, continues to be a major contributor to neurologic morbidity (particularly seizures and epilepsy) in most of the developing world, and a common diagnosis in immigrant populations in the USA and other industrialized countries. Anti-parasitic treatment destroys the brain cysts and improves the prognosis of the seizure disorder. The combination of albendazole (ABZ) plus praziquantel (PZQ) is more efficacious than ABZ alone in cases with multiple viable brain cysts, and recent publications also suggest increased efficacy in individuals with mild infections (one to two lesions, by far the most form of presentation in the Indian subcontinent, as well as in pediatric populations worldwide, in travelers to endemic regions, and in non-endemic regions such as the US). Still the efficacy of the best available regimens offer less than 70% efficacy in parenchymal brain NCC with one to two lesions. The recent development of oxfendazole (OXF) as a potential anti-parasitic agent for human use may provide a new, practical tool with increased efficacy and easier administration. We will perform a three-arm double blind, randomized controlled trial in six centers in two different geographic regions, three in India and three in Peru, to evaluate whether a single dose regime of OXF results in comparable efficacy to the currently used 10 day regime of ABZ plus PZQ, and also whether a 3-dose course of OXF can offer increased parasiticidal efficacy. The study cohort will also allow identification of early imaging markers that may predict lesion resolution in response to anti-parasitic treatment, and will provide additional data on the safety of oral OXF and factors associated to residual scarring, seizure relapses, or reduced quality of life in this population. Finally, systematic sampling in the cohort will provide defined batteries of DNA, white blood cells, serum and urine samples for future evaluation of diagnostic assays for single-lesion parenchymal NCC.

奥芬达唑在脑囊虫病中的主要研究者/项目负责人：GARCIA，Hector H。 单次和三次给药的多中心随机对照试验 奥芬达唑治疗轻度（一个或两个病灶） 实质性脑囊虫病 总结 猪带绦虫脑囊虫病（NCC），由囊状绦虫感染人类中枢神经系统， 猪带绦虫幼虫仍然是神经系统疾病（特别是癫痫发作）的主要原因 和癫痫症），在大多数发展中国家的移民人口中， 美国和其他工业化国家。抗寄生虫治疗破坏了脑囊肿， 癫痫的预后。阿苯达唑（ABZ）与吡喹酮（PZQ）联合用药， 在多发性存活脑囊肿的病例中， 在轻度感染（一到两个病灶，迄今为止大多数形式的 在印度次大陆，以及世界各地的儿科人群中， 流行地区和非流行地区，如美国）。仍然是现有最好的疗效 方案在具有一到两个病灶的脑实质NCC中提供小于70%的疗效。近期 开发奥芬达唑（OXF）作为人类使用的潜在抗寄生虫剂可以提供新的， 实用的工具，提高了效率和更容易管理。我们将进行三臂双盲， 在两个不同地理区域的六个中心进行的随机对照试验，三个在印度，三个在 秘鲁，以评价OXF的单剂量方案是否产生与目前使用的 10天的ABZ加PZQ方案，以及3剂量的OXF疗程是否可以提供增加的杀寄生虫作用。 功效研究队列还将允许识别可能预测病变的早期成像标记物 的决议，以应对抗寄生虫治疗，并将提供更多的数据，口服OXF的安全性 以及与该人群中残留瘢痕、癫痫复发或生活质量降低相关的因素。 最后，队列中的系统采样将提供定义的DNA、白色血细胞、血清 和尿液样本，用于将来评价单病灶实质NCC的诊断测定。